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4-Point TAP Block vs. Combined RSB-OSTAP Block for Recovery After Laparoscopic Cholecystectomy

ConditionsPostoperative PainQuality of Recovery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKonya City Hospital

About this trial

Laparoscopic cholecystectomy is a common keyhole surgery to remove the gallbladder. Although the cuts are small, patients can still have significant pain and nausea after the operation, which may delay recovery and discharge. To improve comfort, doctors often use ultrasound-guided abdominal nerve blocks as part of multimodal pain management.

In this single-center, randomized controlled trial, adult patients scheduled for elective laparoscopic cholecystectomy will receive standard general anesthesia and be randomly assigned to one of two routinely used block techniques at the end of surgery: (1) a 4-point transversus abdominis plane (TAP) block, or (2) a combined bilateral rectus sheath block plus oblique subcostal TAP block. Both techniques are performed under ultrasound guidance while the patient is still asleep.

The main aim of the study is to compare the quality of recovery on the first day after surgery between the two groups, using a short questionnaire (QoR-15). Secondary aims are to compare pain scores, the need for additional pain medicine, and the frequency of postoperative nausea and vomiting between the groups during the first 24 hours. All other aspects of anesthesia and surgical care will follow standard hospital practice. Participation is not expected to add significant risk beyond that of routine anesthesia and surgery, as both block techniques are already commonly used in clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 4-Point TAP (4QTAP) Group

    Procedure/Surgery

    4-Point TAP (4QTAP) Group: Ultrasound-guided 4-point transversus abdominis plane block will be performed at two subcostal and two lateral injection points. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point).

  • RSB + OSTAP Group

    Procedure/Surgery

    RSB + OSTAP Group: Ultrasound-guided bilateral rectus sheath block (two injection points) combined with bilateral oblique subcostal TAP block (two injection points) will be performed. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point).

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: 4-Point TAP (4QTAP) GroupExperimental treatment 1 intervention
Group B: RSB + OSTAP GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Recovery score (QoR-15)

The Quality of Recovery-15 (QoR-15) questionnaire will be used to assess postoperative recovery quality at 24 hours after surgery. The QoR-15 scale ranges from 0 to 150 points, with higher scores indicating better recovery quality.

Time frame
24 hours

Secondary outcomes

1

Postoperative pain score (VAS)

Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at predefined time points. The VAS scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate worse pain.

Time frame
30 minutes, 2 hours, 8 hours, and 24 hours after surgery.
2

Incidence of postoperative nausea and vomiting (PONV)

Presence and severity of nausea (0-3 scale) and vomiting episodes (0-3 scale).

Time frame
First 24 hours postoperative.
3

Antiemetic requirement

Number of patients requiring intravenous ondansetron based on nausea (≥2) or vomiting (≥1).

Time frame
First 24 hours postoperative.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Konya City Hospital

Lead sponsor

Source ClinicalTrials.gov

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